CBT for Insomnia in Breast Cancer Survivors

(COIN Trial)

Recruiting at 3 trial locations

Overseen By Katie Smith, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Sedative hypnotics

Disqualifiers: Bipolar, Psychotic, Seizure, Autoimmune, others

Compensation: Varies

Number of Visits: 30

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that cause sleep disturbances or weight changes. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Insomnia (CBT-I) in breast cancer survivors?

Research shows that Cognitive-Behavioral Therapy for Insomnia (CBT-I) is effective in reducing insomnia symptoms in breast cancer survivors, improving their sleep, quality of life, and mood. Internet-delivered CBT-I (iCBT-I) has also been shown to be effective in this group, making it more accessible for those who cannot attend in-person sessions. ^{1 2 3 4 5}

Is cognitive-behavioral therapy for insomnia (CBT-I) safe for humans?

Cognitive-behavioral therapy for insomnia (CBT-I) is generally considered safe for humans, including cancer survivors. It is a non-drug treatment that focuses on changing sleep-related thoughts and behaviors, and studies have shown it can improve sleep and quality of life without significant safety concerns. ^{2 3 4 6 7}

How is the treatment CBT-I for insomnia in breast cancer survivors different from other treatments?

CBT-I (Cognitive-Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors, and it can be delivered over the internet, making it more accessible for breast cancer survivors who may have difficulty accessing traditional therapy sessions. ^{2 3 4 8 9}

Research Team

Janelle Wilder Coughlin, PHD

Principal Investigator

Johns Hopkins University

Michael Smith, PHD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for overweight or obese female breast cancer survivors, aged 18+, who have insomnia. They must be willing to lose weight and have completed cancer treatments at least 3 months prior. Exclusions include other sleep disorders (except mild apnea), drug abuse, current smokers, or those with unstable psychiatric conditions.

Inclusion Criteria

I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.

You have trouble falling asleep or staying asleep for more than 30 minutes on most nights.

You have a score of 9 or more on a test that measures how bad your insomnia is.

Exclusion Criteria

I am not planning to join any sleep or weight loss programs and my sleep test shows moderate to severe issues.

I do not have any serious health or mental conditions that could interfere with treatment.

I have a sleep disorder other than insomnia, but if it's sleep apnea, it's under control with PAP therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 video visit

Sleep Intervention

Participants undergo a cognitive-behavioral intervention for insomnia (CBT-I) or a sleep education control (EDU) over 8 weeks

8 weeks

6 video sessions

Behavioral Weight Loss (BWL)

Participants engage in a behavioral weight loss program using social cognitive theory and motivational interviewing

12 months

19 video sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 in-person assessment visits

Treatment Details

Interventions

• Cognitive-Behavioral Therapy for Insomnia (CBT-I)
• Sleep Education Control (EDU)

Trial Overview The study tests if Cognitive-Behavioral Therapy for Insomnia (CBT-I) enhances the effectiveness of a subsequent behavioral weight loss program compared to just receiving sleep education followed by the same weight loss program in women who've had early stage breast cancer.

Participant Groups

Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I) Experimental Treatment 1 Intervention

The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be \~60 mins, and remaining visits are \~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.

Group II: Sleep Education Control (EDU) Placebo Group 1 Intervention

The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive-Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic insomnia
• Sleep disturbances in cancer survivors

Approved in European Union as Cognitive-Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic insomnia
• Sleep disturbances in cancer survivors

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment for insomnia in breast cancer survivors, significantly improving sleep quality, mood, and overall quality of life based on a review of 16 studies.

The benefits of CBT-I, including reductions in fatigue and menopausal symptoms, are durable, lasting up to 12 months after treatment, highlighting its potential as a long-term solution for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. Aricò, D., Raggi, A., Ferri, R.[2020]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

The Sleep Treatment Education Program-1 (STEP-1) significantly reduced insomnia symptoms in cancer survivors, with mean Insomnia Severity Index scores dropping from 15.73 at baseline to 9.73 at one-month follow-up, indicating its potential efficacy as a treatment.

STEP-1 can be effectively delivered via videoconference, making it a more accessible option for cancer survivors who may face barriers to traditional therapy, thus improving their chances of receiving necessary insomnia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. Chevalier, LL., Fine, E., Sharma, A., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

In a pilot study involving 21 breast cancer survivors, individual cognitive behavioral therapy for insomnia (IND-CBT-I) significantly improved self-rated insomnia and sleep quality compared to a delayed treatment control group.

The results suggest that IND-CBT-I is a practical and effective option for improving sleep in breast cancer survivors, making it accessible in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Fiorentino, L., McQuaid, JR., Liu, L., et al.[2021]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]